Optimize Neoadjuvant Therapy in HER2-Positive Early-Stage Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This is an open-label phase 2 study to evaluate the pCR rate in patients diagnosed with HER2 positive breast cancer treated on an adaptive clinical trial design. Tumors will undergo testing using a novel molecular phosphoprotein-based biomarker assay, HER2 Activation Response Predictive Signature (HARPS) to identify HARPS-positive breast cancers. To assess 3-year invasive disease-free survival (iDFS) in patients with HARPS-positive and HARPS-negative HER2-positive breast cancer. To correlate changes in ctDNA with treatment outcomes in patients with HARPS-positive and HARPS-negative HER2-positive breast cancer. To understand the changes in quality of life (QOL) measure in patients with HARPS-positive HER2-positive breast cancer treated using an adaptive neoadjuvant trial design.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Guz piersi większy niż 2 cm lub obecność przerzutów do węzłów chłonnych.
- •Rak piersi musi być HER2-dodatni (potwierdzony testem IHC 3+ lub IHC 2+ i FISH).
- •Pacjentka musi mieć zbadany status receptorów estrogenowych (ER) i progesteronowych (PR).
- •Wystarczająca ilość tkanki guza do badania nowym biomarkerem HARPS.
- •Pobranie próbki krwi do badania ctDNA przed rozpoczęciem leczenia.
- •Możliwość wykonania rezonansu magnetycznego (MRI) piersi.
- •Poprawna funkcja serca (frakcja wyrzutowa LVEF > 50%).
- •Brak wcześniejszego leczenia chemioterapią z grupy antracyklin.
✗ Disqualifies
- •Wcześniejsze leczenie chemioterapią, lekami anty-HER2, radioterapią lub hormonoterapią z powodu raka piersi.
- •Guz o zaawansowaniu cT4 lub przerzuty do licznych węzłów chłonnych (cN3).
- •Stwierdzenie obecności przerzutów odległych (choroba rozsiana).
- •Rak piersi w obu piersiach.
- •Inne choroby nowotworowe w ciągu ostatnich 5 lat (z pewnymi wyjątkami).
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 90 Years
- Last updated (source)
- April 23, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (7)
RWJBarnabas Health - Trinitas Hospital and Comprehensive Cancer Center
Elizabeth, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, Hamilton
Hamilton, United States
RWJBarnabas Health - Monmouth Medical Center
Long Branch, United States
Rutgers Cancer Institute
New Brunswick, United States
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, United States
RWJBarnabas Health - Robert Wood Johnson University Hospital, Somerset
Somerville, United States
RWJBarnabas Health - Community Medical Center
Toms River, United States
Trial contact
Mridula A George
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.